Addressing racism is necessary to boost representation in MS clinical trials

Key takeaways:

• Ensuring the best representation in clinical trials requires a greater commitment to underserved groups.
• Communication, reflection and correction of biased thoughts and behaviors are key to establishing trust.

ORLANDO, Fla. — The highest priority in boosting clinical trial representation in MS is utilizing corrective methods to reverse generational actions that led to mistrust in affected groups or individuals, according to a speaker.

“The incidence of multiple sclerosis is highest in Black women, so the fact that trials don’t at all reflect the people who experience and live with MS is a major problem,” Ellen M. Mowry, MD, MCR, director of Multiple Sclerosis Experimental Therapeutics program at Johns Hopkins University School of Medicine, said at the American Neurological Association annual meeting.

According to a wealth of research cited by Mowry, there are several obstacles to greater representation in clinical trials. Bias is an important one, she said.

There is an assumption that Black individuals are less likely to participate in trials due to mistrust. This, however, is not true, Mowry said. Rather, studies show that Black individuals are interested in clinical trials, “they just have healthy skepticism about their safety in some cases,” she added. But when study team members “have these biases” and assume a patient is not interested in a study, data show that it influences the way team members describe the study to eligible participants, according to Mowry. In these cases, the study team members “are actually perpetuating racism,” she said.

“Mistrust is not the problem,” she said. “The problem is racism.”

Other factors that drive inequities include geographic misalignment of trial sites, overwhelmingly in the Western and Northern hemispheres, along with clinical trial design, recruitment and training.

To address site selection issues, Mowry suggested looking beyond academic centers, or clinics without experience with underrepresented groups or populations. Instead, she offered, researchers need to engage more with communities of interest well ahead of time to foster trust and understanding, an investment of time which may be contrary to the goals of the funding source.

Tackling issues of trial design itself, Mowry revealed that greater input from underrepresented groups regarding design, recruitment and implementation are a must, along with strong considerations for recruiting methods (language, communication strategy, eligibility criteria) and materials to be as inclusive as possible to a target population. Additionally, clinicians should pay particular attention to scheduling and insurance concerns, Mowry added, with investigators possibly covering associated enrollment and travel costs.

Improving recruitment must begin with allowances for a minimum acceptable number of underrepresented persons, she said.

Based on Mowry’s personal experience with recruitment, she revealed that eligibility lists should be sorted initially with a focus on these individuals, then conversations should take place with otherwise ineligible persons with kinship to underserved communities to assist in recruitment. Trust is paramount, she added, with honesty and relatability at the head and heart of building trust, alongside establishing effective relationships with localized referral sources, building a representative study team and allowing for constructive dialogue that permits admission of past wrongdoing.

Training study teams, Mowry said, will involve greater cultural competency, recognition and correction of bias, as well as examination and correction of behavioral patterns which may have led to cultural and generational mistrust.

Among other considerations for changing the clinical trial recruitment paradigm, according to Mowry, are attention to intersectionality, not only by race and economics but also demographic, language, immigration status, insurance eligibility, sexuality and gender.

“Minoritized individuals are at higher risk of dropping out of trials,” Mowry noted. “We try never to withdraw a person who is enrolled in a trial because we lose their information. Prioritize getting the outcomes you really care about.”